RecruitingNot ApplicableNCT06604208

Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"

Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"

Sponsor

Chang Gung Memorial Hospital

Enrollment

74 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Insomnia Chronic

Summary

The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are: What medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia. Participants will: Using binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests

Eligibility

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether listening to binaural beats — an audio therapy that plays slightly different sound frequencies in each ear to influence brainwave activity — can improve sleep quality in adults with chronic insomnia compared to a placebo sound. Chronic insomnia affects about 10% of the global population and is linked to health conditions including hypertension and diabetes, making non-drug treatments an important area of research. Eligible participants are adults aged 20–75 who meet DSM-5 criteria for insomnia (difficulty sleeping at least 3 nights per week for at least 3 months) and do not have severe psychiatric disorders, other major sleep disorders like severe sleep apnea, or unstable medical conditions. Participation involves listening to the binaural beat device (or placebo audio) for at least 30 minutes each night for 2 weeks, keeping a sleep diary, wearing an actigraphy monitor, and attending a follow-up clinic visit. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBinaural Beats

The binaural beat device is a health product that is not classified as a medical device. It functions similarly to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials. The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats be listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.

DEVICEPlacebo

Placebo